Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores

Richard H Osborne; Lauren M Nelson; Sheri Fehnel; Nicole Williams; Randall H Bender; Ryan Ziemiecki; Efi Gymnopoulou; Els De Paepe; Yannick Vandendijck; Lindsey Norcross; Esther Heijnen; Gabriela Ispas; Christy Comeaux; Benoit Callendret; Eric K H Chan; Jane A Scott

doi:10.1186/s41687-023-00593-9

Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores

J Patient Rep Outcomes. 2023 Jun 1;7(1):51. doi: 10.1186/s41687-023-00593-9.

Authors

Richard H Osborne^{1

2}, Lauren M Nelson³, Sheri Fehnel³, Nicole Williams³, Randall H Bender³, Ryan Ziemiecki³, Efi Gymnopoulou⁴, Els De Paepe⁴, Yannick Vandendijck⁴, Lindsey Norcross³, Esther Heijnen⁴, Gabriela Ispas⁴, Christy Comeaux⁴, Benoit Callendret⁴, Eric K H Chan⁵, Jane A Scott⁶

Affiliations

¹ Measured Solutions for Health, P.O. Box 5127, Alphington, VIC, 3079, Australia. richard.o@measuredsolutions.com.au.
² Centre of Global Health and Equity, Swinburne University of Technology, Hawthorn, VIC, Australia. richard.o@measuredsolutions.com.au.
³ RTI Health Solutions, Research Triangle Park, NC, USA.
⁴ Janssen Infectious Diseases, Beerse, Antwerp, Belgium.
⁵ Janssen Global Services, Raritan, NJ, USA.
⁶ Janssen Global Services, High Wycombe, Buckinghamshire, UK.

Abstract

Background: The Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) is a patient-reported outcome measure designed to assess symptoms and impacts of respiratory syncytial virus (RSV) infection. This study evaluated the construct validity, reliability, and responsiveness of the RiiQ™ Respiratory and Systemic Symptoms Scale scores.

Methods: Prospective data were analyzed from a total of 1795 participants, including from non-hospitalized patients with acute respiratory infection (ARI) and no coinfections enrolled in a Phase 2b RSV vaccine study (RSV-positive: n = 60; RSV-negative: n = 1615), and two observational studies of patients hospitalized with RSV (n = 20; n = 100). Descriptive statistics, confirmatory factor analysis (CFA), test-retest intraclass correlation coefficients (ICCs), construct validity correlations (between a clinician-assessed clinical questionnaire and the RiiQ™ symptoms scale), known-groups validity, and responsiveness (correlations of change scores) were evaluated.

Results: Mean patient age ranged from 66.5 to 71.5 years and the majority of patients were female. Initial assessments in the vaccine trial (ARI Day 1) were suggestive of less severe illness than in the observational studies with hospitalized patients. CFA loadings (> 0.40) supported summary scores. ICCs exceeding the recommended threshold of 0.70 supported test-retest reliability for Respiratory and Systemic Symptoms, except in the small observational study. At the scale level, correlations were moderate to strong (|r| ≥ 0.3) and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity. Correlations with change in Patient Global Impression of Severity > 0.30 supported responsiveness.

Conclusions: Psychometric tests applied to the RiiQ™ Symptoms scales provide evidence of its reliability, construct validity, discriminating ability, and responsiveness for use in clinical studies to assess the onset and severity of RSV symptoms.

Keywords: Patient-reported outcome; Psychometric; Respiratory syncytial virus; RiiQ™; Validation.

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Female
Humans
Male
Prospective Studies
Psychometrics
Reproducibility of Results
Respiratory Syncytial Virus Infections* / diagnosis
Respiratory Tract Infections* / diagnosis